One type of biosimilar insulin was approved by Health Canada for the first time in 2019, and many other types have been made available ever since. People with type 1 diabetes (T1D) will certainly hear a lot more about biosimilar insulin soon, with the Régie de l’assurance maladie (RAMQ) set to stop providing coverage for many types of insulin and replace them with biosimilar insulin products by April 2022.
What is biosimilar insulin?
Biosimilar types of insulin are copies of biologic (or reference) insulin products already on the market.
They are very close to the original product, but are manufactured and marketed by a different company once the original patent is expired.
In order to be authorized by Health Canada, these types of insulin must be proven to be as safe and effective as the reference insulin; for instance, studies must show that they do not cause more hypoglycemic or hyperglycemic episodes or allergic reactions.
Available biosimilar insulin products
There are currently three types of biosimilar insulin available in Canada.
|Reference insulin||Biosimilar insulin|
|Lantus® (Sanofi-Aventis)||→||Basaglar® (Lilly)|
|Humalog® (Lilly)||→||Admelog® (Sanofi-Aventis)|
|Novorapid® (Novo Nordisk)||→||TrurapiTM (Sanofi-Aventis)|
Government push to prioritize biosimilars
Thanks to a much simpler development process, biosimilar insulin products are made available at a lower cost than their reference insulin. For that reason, as part of the government push to promote their use, the RAMQ has stopped covering certain types of reference insulin (e.g., Lantus®, in 2017, and Humalog®, in March 2021) for people wishing to start using them.
People who were already using Lantus or Humalog can still be covered for the time being. However, all biologic (reference) insulin products will need to be replaced gradually by equivalent biosimilars by April 13, 2022. After that date, anyone using a “reference” insulin product will need to transition to a corresponding biosimilar, even if their treatment started before the biosimilars were made available.
Here are a few exceptions:
- Pregnant women must make the transition within 12 months after giving birth.
- Children must make the transition within 12 months after their 18th birthday.
If you are currently using one the biologic insulin types listed above, make sure to ask your healthcare team to change your prescription and insulin pen, as needed.
Even though your insulin doses will stay the same once you transition to your new insulin, you could use the opportunity to assess whether an adjustment could be beneficial (with the help of your healthcare team, if needed).
While these new products are a safe and effective treatment option that could help reduce the cost of insulin in Canada and around the world, the lack of choice in making this transition is rather problematic. The choice of the most appropriate treatment should be left primarily to T1D patients and their healthcare team.
- “Biosimilar biologic drugs in Canada: Fact Sheet”, accessed on November 30, 2021, https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a2
- “Biosimilar drugs”, accessed on November 30, 2021, https://www.quebec.ca/en/health/health-system-and-services/biosimilar-drugs